II. Determine the acute and long-term toxic effects of these regimens in these patients,
including visual outcome and incidence of secondary malignancies.

III. Determine the patterns of failure in patients treated with these regimens, in terms of
vitreous vs retinal vs both as sites of recurrence.

IV. Determine predictors of failure including findings at the on study examination under
anesthesia and response status after six courses of chemotherapy.

V. Determine the percentage of group C and D eyes separately that can be preserved without
enucleation after failing protocol therapy.

OUTLINE: This is a multicenter study.

Patients receive vincristine IV over 1 minute on day 1 and carboplatin IV over 1 hour and
etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF)
subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients
receive subtenon carboplatin to each group C or D eye on day 0 or 1 prior of courses 2-4
only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of
extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic
chemotherapy, patients undergo local ophthalmic therapy comprising local laser and/or
cryotherapy on day 1.

Patients are followed with ophthalmology exams every 4-12 weeks until 3 years of age, every
6 months until 5 years of age, and then annually for up to 10 years.

Inclusion Criteria:

- Diagnosis of bilateral retinoblastoma with at least 1 eye group C or D intraocular
retinoblastoma by ophthalmologic examination, defined by the International
Classification System for Intraocular Retinoblastoma as the following:

Type of Study:

Study Design:

Outcome Measure:

Proportion of failure-free survival of patients with group C and/or D retinoblastoma

Outcome Description:

The observed failure proportion for group D eyes will be compared to the historical proportion of 0.70 using a method suggested by Rosner. The proportion of group C eyes that fail will be compared to the historical probability of 0.40 using the same method.

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